Chinese Journal of Tissue Engineering Research ›› 2016, Vol. 20 ›› Issue (11): 1623-1629.doi: 10.3969/j.issn.2095-4344.2016.11.016

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Cholecystokinin promotes regeneration of the injured common peroneal nerve: study protocol for a prospective, randomized, controlled clinical trial

Chen Xuan-huang, Zheng Feng, Zhang Guo-dong, Li Rong-yi, Lin Hai-bin, Zheng Zu-gao, Cai Han-hua   

  1. Department of Orthopedics, Affiliated Hospital of Putian University, Putian 351100, Fujian Province, China
  • Received:2016-02-05 Online:2016-03-11 Published:2016-03-11
  • About author:Chen Xuan-huang, Master, Associate chief physician, Department of Orthopedics, Affiliated Hospital of Putian University, Putian 351100, Fujian Province, China
  • Supported by:

    the Medical Science and Technology Project of Putian Municipal Science and Technology Department, No. 2012S03(4)

Abstract:

BACKGROUND: Cholecystokinin as an endogenous neuroprotective factor in the nervous system has garnered increasing attention. Findings from previous animal studies show that cholecystokinin can effectively promote the regeneration of the injured peripheral nerve. On this basis, further clinical trials will be performed to observe whether local application of cholecystokinin at nerve anastomosis can promote peripheral nerve regeneration.
METHODS/DESIGN: As a prospective randomized controlled trial, this study will enroll 100 patients with complete rupture of the peroneal nerve, who will be randomly divided into two groups: after nerve suture and partial gelatin sponge infiltration at nerve anastomosis, the patients will be treated with 8 nmol/kg cholecystokinin (treatment group) or saline (control group). At 6, 12, 24 weeks after treatment, common peroneal nerve conduction velocity and electromyography and nerve fiber morphology will be detected; the clinical efficacy at the last follow-up will be assessed; and all adverse events during the follow-up will be recorded to assess the therapeutic efficacy and safety.
DISCUSSION: In this study, cholecystokinin as an inducing agent for nerve growth factor synthesis will be observed and studied, with a view to providing a new idea for seeking peripheral nerve therapy.
ETHICAL APPROVAL: The study protocol was approved by the Medical Ethics Committee of the Affiliated Hospital of Putian University (approval No. 2014116). Written informed consent will be obtained from patients before treatment.